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JNJ-78934804 · 2 trials · 2 indications
Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (\>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
| Arm | Type | Description |
|---|---|---|
| JNJ-78934804 | EXPERIMENTAL | Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind (DB) treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase. |
| Guselkumab | ACTIVE_COMPARATOR | Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete DB treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase. |
| Name | Type | Description |
|---|---|---|
| JNJ-78934804 | DRUG | JNJ-78934804 will be administered subcutaneously. |
| Guselkumab | DRUG | Guselkumab will be administered subcutaneously. |
Inclusion criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. * Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, ...
JNJ-78934804 is an investigational small molecule being studied for the treatment of moderately to severely active Crohn's disease and ulcerative colitis. It is currently in Phase 3 clinical development by Johnson & Johnson for these gastrointestinal inflammatory conditions.
JNJ-78934804 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is currently conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with inflammatory bowel disease.
JNJ-78934804 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Johnson & Johnson is currently recruiting participants for two Phase 3 trials studying the drug in Crohn's disease and ulcerative colitis.
JNJ-78934804 is being studied in two Phase 3 clinical trials. NCT07577843 is evaluating the drug in approximately 460 participants with moderately to severely active Crohn's disease. NCT07577856 is evaluating the drug in approximately 644 participants with moderately to severely active ulcerative colitis. Both trials are currently recruiting.
The mechanism of action of JNJ-78934804 has not been disclosed in available clinical trial information. It is classified as a small molecule therapeutic being developed for the treatment of inflammatory bowel diseases, including Crohn's disease and ulcerative colitis.
No alternative names for JNJ-78934804 have been disclosed. The drug is identified solely by its development code JNJ-78934804 in the clinical trial registrations for its Phase 3 studies in Crohn's disease and ulcerative colitis.